Initial Drug Listing - Roycederm Tea Tree Body Wash

Initial Drug Listing - Roycederm Tea Tree Body Wash
SPL v2
SPL
SPL Set ID 3a2bb86e-36a2-2cd7-e063-6394a90a3fb4
Route
TOPICAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Gleditsia Sinensis Fruit Citric Acid Amino Acids Lentinula Edodes Mycelium Water Cnidium Monnieri Fruit Artemisia Argyi Leaf Sophora Flavescens Root Sauromatum Giganteum Whole Shea Butter Tea Tree Oil Stemona Tuberosa Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01
Description

Tolnaftate 1.0%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Helps relieve and prevent athlete's foot(tinea pedis), jock itch (tinea cruris),ringworm(tinea corporis)
  • Relieves itching, cracking, scaling, and discomfort caused by these fungal infections
Dosage and Administration
  • Apply to body and feet during shower or bath.
  • Gently massage over the entire body,focusing on areas where odor or skin irritation is a concern.
  • After gently washing, rinseand dry skin and feet thoroughly.
  • For Athllete's foot: pay special attention to the spaces between the toes; wear well-fitting,ventilated shoes and change shoes and socks at least once daily. This product is not effective on the scalp or nails.
Description

Tolnaftate 1.0%

Section 50565-1

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

Section 50566-9

Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

Section 50567-7

avoid contact with eyes. lf contact occurs, rinse eyes thoroughly with water.

Section 50569-3

Ask a doctor before use if allergic to anyingredients in this product.

Section 50570-1

on children under 12 of age except under the advice and supervision of a doctor.

Section 51727-6

Purified Water, Artemisia Argyi Leaf, TeaTree Oil, Shea Butter, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit,Lentinula Edodes (Shiitake Mushroom)Extract, Gleditsia Sinensis Fruit, Typhonium Giganteum Whole, Stemona Tuberosa Root, Citric Acid, Amino Acids

Section 51945-4

Section 53413-1

Email [email protected]

Section 53414-9

ask a health professional before use

Section 55105-1

Anti-Fungal

Section 55106-9

Tolnaftate 1.0%

Section 60561-8

Store at 20° to 25°C(68° to 77°F) and out of direct sunlight.

Structured Label Content

Indications and Usage (34067-9)
  • Helps relieve and prevent athlete's foot(tinea pedis), jock itch (tinea cruris),ringworm(tinea corporis)
  • Relieves itching, cracking, scaling, and discomfort caused by these fungal infections
Dosage and Administration (34068-7)
  • Apply to body and feet during shower or bath.
  • Gently massage over the entire body,focusing on areas where odor or skin irritation is a concern.
  • After gently washing, rinseand dry skin and feet thoroughly.
  • For Athllete's foot: pay special attention to the spaces between the toes; wear well-fitting,ventilated shoes and change shoes and socks at least once daily. This product is not effective on the scalp or nails.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

Section 50566-9 (50566-9)

Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

Section 50567-7 (50567-7)

avoid contact with eyes. lf contact occurs, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)

Ask a doctor before use if allergic to anyingredients in this product.

Section 50570-1 (50570-1)

on children under 12 of age except under the advice and supervision of a doctor.

Section 51727-6 (51727-6)

Purified Water, Artemisia Argyi Leaf, TeaTree Oil, Shea Butter, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit,Lentinula Edodes (Shiitake Mushroom)Extract, Gleditsia Sinensis Fruit, Typhonium Giganteum Whole, Stemona Tuberosa Root, Citric Acid, Amino Acids

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email [email protected]

Section 53414-9 (53414-9)

ask a health professional before use

Section 55105-1 (55105-1)

Anti-Fungal

Section 55106-9 (55106-9)

Tolnaftate 1.0%

Section 60561-8 (60561-8)

Store at 20° to 25°C(68° to 77°F) and out of direct sunlight.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:17.055846 · Updated: 2026-03-14T23:10:33.744870